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Status unknownNCT02233205Updated Jul 24, 2015

Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System

A Phase 1/2 interventional study of ultrasonic microbubbles and platinum and gemcitabine in Gastrointestinal Neoplasms, sponsored by Peking University Cancer Hospital & Institute. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-07-24.

Sponsored by Peking University Cancer Hospital & Institute · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects. The main purpose is to identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.

Read the detailed description

Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects.

  1. Main purpose

    1. To identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.
    2. To explore the largest mechanical index and ultrasonic treatment time which patients can endure.

  2. Secondary purpose

    1. To observe tumor clinical benefit rate (CR+PR+SD).
    2. To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)
02

Conditions studied

  • Gastrointestinal Neoplasms

Keywords

  • microbubble
  • chemotherapy
  • alimentary
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 18 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma
  • Failed routine chemotherapy
  • Neoplasms can be evaluated by imaging
  • ECOG《2

Exclusion criteria

Exclusion Criteria:

  • Have systematic chemotherapy in 2 weeks
  • Be allergic to ultrasonic microbubbles and chemotherapeutics
  • Uncontrolled high blood pressure, cardiovascular disease
  • Active bleeding
  • Have serious mental and psychological disease
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    microbubbles & platinum and gemcitabine

    In 30min after chemotherapy, inject ultrasonic microbubbles 1 ml once and inject 5 times in 20min and locate the ultrasonic probe on the lesion The chemotherapy of pancreatic is gemcitabine.The chemotherapy of liver metastases is oxaliplatin with taxol.

    Device: ultrasonic microbubbles · Drug: platinum and gemcitabine

Interventions

  • Deviceultrasonic microbubbles

    inject 1ml once and five times in 20min, locate the probe on the lesion at the same time

    Also known as: Sonovue

  • Drugplatinum and gemcitabine

    Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.

06

What researchers measure

Primary outcomes

  1. Number of Participants with Serious and Non-Serious Adverse Events

    Time frame: 1 month

Secondary outcomes

  1. Time to Disease Progression

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, 100142, China
    • Wei Yang, Doctor · Contact · 13681408183@163.com · 0086-10-88196195
    • Yanjie Wang, Doctor · Contact · philinsss@163.com · 0086-10-88196941
    • Yan Li, Doctor · Sub investigator
    • Wei Yang, Doctor · Sub investigator
    • Jifang Gong, Doctor · Sub investigator
    Recruiting
08

References and documents

Publications

  • Kotopoulis S, Dimcevski G, Gilja OH, Hoem D, Postema M. Treatment of human pancreatic cancer using combined ultrasound, microbubbles, and gemcitabine: a clinical case study. Med Phys. 2013 Jul;40(7):072902. doi: 10.1118/1.4808149. PubMed 23822453 ↗
  • Dewitte H, Van Lint S, Heirman C, Thielemans K, De Smedt SC, Breckpot K, Lentacker I. The potential of antigen and TriMix sonoporation using mRNA-loaded microbubbles for ultrasound-triggered cancer immunotherapy. J Control Release. 2014 Nov 28;194:28-36. doi: 10.1016/j.jconrel.2014.08.011. Epub 2014 Aug 22. PubMed 25151979 ↗
  • Fan Z, Kumon RE, Deng CX. Mechanisms of microbubble-facilitated sonoporation for drug and gene delivery. Ther Deliv. 2014 Apr;5(4):467-86. doi: 10.4155/tde.14.10. No abstract available. PubMed 24856171 ↗
  • Feichtinger GA, Hofmann AT, Slezak P, Schuetzenberger S, Kaipel M, Schwartz E, Neef A, Nomikou N, Nau T, van Griensven M, McHale AP, Redl H. Sonoporation increases therapeutic efficacy of inducible and constitutive BMP2/7 in vivo gene delivery. Hum Gene Ther Methods. 2014 Feb;25(1):57-71. doi: 10.1089/hgtb.2013.113. Epub 2013 Nov 27. PubMed 24164605 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02233205
Lead sponsor
Peking University Cancer Hospital & Institute
Responsible party
Kun Yan (chief director, Peking University Cancer Hospital & Institute) — Principal investigator
First posted
Sep 8, 2014
Start date
Oct 2014
Primary completion
Dec 2015 (estimated)
Completion
Jun 2016 (estimated)
Last update
Jul 24, 2015

Study contacts

Yang Wei, Doctor
Contact
13681408183@163.com
0086-10-88196195
Yanjie Wang, Doctor
Contact
philinsss@163.com
0086-10-88196941
Kun Yan, Master
principal investigator · Peking University Cancer Hospital & Institute
Lin Shen, Doctor
principal investigator · Peking University Cancer Hospital & Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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